Main responsibilities:

• Direct the development of clinical strategies and plans to integrate the company’s compounds into the standard practice of immuno-oncology.
• Lead and supervise all aspects of Clinical Development & Clinical Operations.
• Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results.
• Lead interactions with academic thought leaders, investigators, cooperative groups, and other clinical stakeholders.
• Oversight of CROs and other vendors as necessary.
• Give input into portfolio and pipeline development and advancement.
• Provide clinical support and contribute, together with other members of the management team, to the development of the overall corporate strategy
• Represent the company and its programs in front of external audiences, such as investment, medical and regulatory communities, as well as pharma and biotech companies.
• Identify, develop, and maintain strong working relationships with investigators and KOLs.
• Provide input into non-project work and the development of clinical R&D procedures.
• Lead the preparation of regulatory briefing documents and clinical elements of regulatory submission documents (IND, CTA, NDA, BLA, MAA).
• Serve as the subject matter expert for Clinical/Medical programs to the rest of the organization.
• Step in to represent the CMO on an as-needed basis.

Requirements and skills:

• MD with solid Medical Affairs & Clinical Development industry experience.
• Must have experience with and strong knowledge of Oncology drug development; experience in Immuno-Oncology is a plus.
• Solid experience in leading clinical groups including clinical/medical affairs and clinical operations.
• A proven success record in Phase I-III clinical research studies and trial design as well as successful submission of IND and marketing approval-directed filings (BLA’s, NDA’s, and MAA’s).
• Knowledge of relevant EMA and FDA regulations and guidelines as well as those of other
• health authorities; experience in interactions with EMA and FDA personnel is essential;
• experience in interactions with other health authorities a plus.
• Must have a thorough knowledge of clinical research concepts, practices, and applicable
• regulations such as GCP and ICH guidelines.
• Experience in translational medicine, clinical pharmacology and early stage development incl. CMC is desirable.
• Must have excellent leadership and interpersonal skills.
• Excellent verbal and written communication skills. Comfortable presenting in public meetings or expert level settings; demonstrated excellence in stakeholder management at any level.
• Agility and resourcefulness in response to unexpected challenges or dynamic situations.
• Ability to make difficult, high-stake decisions and provide credible leadership.
• Patience, fairness and loyalty in interactions with colleagues.
• Willingness to travel and work long hours as needed.
• Cross-functional and adaptive; the company has a lean team and versatility to support non-core activities is a plus.

• Gestión transversal de todos los aspectos relacionados con los proyectos de licencia y suministro de medicamentos propios a laboratorios terceros, siendo responsable de la línea de productos encomendada.
• Eso incluye:
  • Análisis de mercados e identificación de oportunidades.
  • Selección de potenciales socios.
  • Presentación de productos a potenciales socios.
  • Negociación de contratos.
  • Colaboración y coordinación entre distintos departamentos internos, tales como regulatorio, investigación, producción, etc.
  • Apoyo a socios en materias de marketing, planificación de producción, stocks,..

• Experiencia mínima de tres años, en posición similar dentro del sector farmacéutico, ya sea con medicamentos innovadores, genéricos o biosimilares.
• Se valorará especialmente experiencia en Out-Licensing internacional.
• Formación en ciencias de la vida, especialmente en Farmacia.
• Se valorará formación adicional en negocio, tipo MBA, comercio internacional, etc.
• Nivel de inglés muy alto.
• Se valorará la experiencia en gestión de proyectos.
• Se valorará los conocimientos de Market Access internacional.
• Capacidad de trabajo en equipo.
• Autonomía y proactividad.

• Incorporarse a un sólido grupo farmacéutico en fase de expansión.
• Posición de alta visibilidad.

• Work independently or supervise associates to plan for and execute design and development of immunoassays.
• Comply with all company policies and SOPs as well as regulatory requirements for the design, analysis and reporting of research projects and products under ISO13485 and 21CFR820.
• Prepare experiment and product documentation including summary reports.
• Write SOPs and assemble batch records.
• Present results to colleagues and management team.
• Develop new methods and train laboratory personnel.

• PhD in Life Sciences or related field. MSc may be considered with additional years of experience.
• Minimum of five years of laboratory experience with proven hands-on technical abilities in immunoassay development, antibody-based platform test and evaluation.
• Proven experience in management of research projects, including training of other scientists, lab associates, and support personnel, analyzing data, and writing reports.
• Fluent English.
• Team player and proactive professional.

• Joining a very important and solid multinational Group.
• Being involved in a strategic project, collaborating with international teams.

• Implementation and supervision of the development plan
• Coordination of the internal development team.
• Interaction with all stakeholders to ensure flawless execution within the agreed deadlines.
• To coordinate third-party activities and external stakeholders such as CDMOs.
• Prepare periodical status updates and present them to Senior Management.

• PhD in Molecular Biology, experience in the area of advanced therapies is a plus.
• Experience in drug discovery.
• Technical leadership and experience in managing small R&D teams.
• Strong organizational and analytical capacities.
• Effective communication and presentation skills at all levels and to a variety of stakeholders.
• Agility and resourcefulness in a fast moving environment and in response to unexpected challenges or situations.
• Team player.
• Fluency in English.
• Based in Valencia or willing to spend several days per week in Valencia.

• Communicate the Voice of Customer to internal development teams to frontload product development that ensures value creation in new products.
• Closely manage the lifecycle for responsible products and significantly contribute to the company’s growth and profitably through portfolio management, strategic pricing and new product enhancements.
• Provide market intelligence, business cases and Voice of Customer requirements for new product development or new market program development within the own area of responsibility.
• Create and implement clear value proposition /positioning for covered products incorporating Sample to Insight messaging.  Includes training regional teams for new product launches and driving uptake of new launches with Comm Ops.
• Product/platform life cycle management and strategic product development roadmap that considers phasing out older or less profitable product lines for new innovations.
• Strategic pricing that generates maximum profitability based on value product brings to the market and current competitive atmosphere. Actively incorporating Value Based Pricing principles in new product launches.
• Be up-to-date on the latest regulatory and clinical trial requirements.

• Education in Life Sciences, MBA is a plus.
• 3 years experience in clinical IVD marketing/ commercial organizations.
• Experience in molecular diagnostics is a plus.
• Some customer facing and international business experience is required.
• Commercial mind-set able to adapt to different markets Europe, US, and Emerging Markets.
• Excellent interpersonal and communication skills at all levels and with a variety of stakeholders incl. effective KOL management
• Ability to advance projects and promote collaboration in a matrixed environment.
• Strategic vision, ability to make and defend difficult, high-stake trade-off decisions.
• Agile with intellectual curiosity, resourcefulness in response to unexpected challenges or dynamic situations.
• Willingness to travel extensively.
• Fluency in English.

-Coordinate the validation of analytical methods to quantify drugs, anti-drug antibodies or biomarkers in biological matrices by ligand binding assays (ELISA, MSD) according to international guidelines.
-Coordinate sample analysis projects, including regulated and non-regulated, pre-clinical and clinical studies.
-Manage method development projects.
-Deliver extensive and effective communication with sponsors and timely delivery of results.
-Organize and line-manage laboratory personnel.
-Effectively resolve technical and regulatory issues.
-Actively support Senior Management and participate in strategic projects to optimize procedures.

-PhD, MSc or BSc in biology or related subject.
-Minimum 3-years’ experience in bioanalytical CROs.
-Experience working with ELISA, MSD or other Ligand Binding techniques.
-Experience in managing validation and sample analysis projects for determination of Immunogenicity and PK for pre-clinical and clinical studies
-Deep understanding of international bioanalytical guidelines for PK and Immunogenicity assay validation, and experience working under GLP/GCP regulations.
-Experience working with LIMS systems.
-Experience working with cell culture techniques will be highly valued
-Excellent level of English (Spanish – nice to have).

-Opportunity to work and contribute to the success of an expanding CRO.
-Solid scientific team with career growth opportunities.
-Cutting edge laboratory with the latest technology.
-International and multicultural environment in company based in Barcelona.
-Diligent, professional organization, with a human touch.